Kornimate/medical-research-clean huggingface dataset:
cardiometabolic program meets ehealth: redesign and evaluation for optimal reach and impact

Conditions: Obesity; Metabolic Syndrome; Pre-diabetes; Type 2 Diabetes; Cardiovascular Disease

Summary: the ecmp pilot aims to study the feasibility and potential effectiveness of an electronically-mediated cardiometabolic program (ecmp) for therapeutic lifestyle change among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.

the ecmp is an evidence-based lifestyle intervention using a holistic, mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using existing web and mobile technologies. in this pragmatic randomized controlled trial, participants will be recruited from primary care patients of an integrated ambulatory care system. they will be randomly assigned to receive the ecmp upon completion of baseline data collection (the immediate intervention group) or after 3 months (the delayed intervention group). all participants will be assessed at 0, 3 and 6 months. outcomes include common cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose), health behaviors (e.g., dietary intake and physical activity), and indicators of ecmp engagement and adherence (e.g., attendance and self-monitoring).

Eligibility criteria:
inclusion criteria: * english-speaking adults aged 18+ years * high-risk primary prevention: bmi 35+ and prediabetes (including hx of gestational diabetes) and/or metabolic syndrome * secondary prevention: bmi 30+ and type 2 diabetes and/or cardiovascular disease * able and willing to provide written informed consent exclusion criteria: * medical determination that the study is inappropriate or unsafe for the patient * type 1 diabetes * safety concerns related to significant physical or mental health issues or life expectancy of less than 12 months * currently pregnant or lactating * no regular telephone or broadband internet access or otherwise unable to participate in the intervention

Keywords: ecmp ehealth mhealth lifestyle intervention cardiometabolic risk reduction pamf
newer breast mri sequences for the evaluation of breast cancer -fiesta, vibrant-de and ideal: feasibility evaluation

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate new computer software on breast magnetic resonance imaging (mri). the information from this study may help doctors and scientists develop better ways to find breast cancer, and may help future patents with cancer.


Eligibility criteria:
inclusion criteria: * female patients over the age of 21 undergoing a diagnostic breast mri. exclusion criteria: * patients who would be normally excluded from undergoing an mri examination * patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field. * patients under the age of 21. * female patients who are pregnant.

Keywords: vibrant-de ideal mri breast 07-091
prospective validation of aki prediction

Conditions: Acute Kidney Injury

Summary: the purpose of this prospective observational study is to implement, deploy, and quantify accuracy of an existing pediatric early aki risk score algorithm. the implementation will be facilitated using a health level 7 (hl7) fast healthcare interoperability resource (fhir)-based architecture. investigators will deploy this model and store results in a manner not viewable to the clinical team caring for the patient. to determine the accuracy of the implemented prediction model, investigators will prospectively identify patients with aki at 72 hours following icu admission. investigators hypothesize that this model will prospectively detect aki with a sensitivity \>70% and a positive predictive value \>20%, both chosen a priori as 10% improvement over the initial pediatric aki risk score tool.

this is a single-center prospective observational study validating an aki predictive model. each model feature will be mapped to an appropriate fhir-based resource. to mitigate the latency issues seen in other distributed cds systems, investigators have developed an asynchronous design where algorithm calculations are performed offline (e.g., not within the ehr) and risk scores are subsequently written back to the ehr. importantly, in this deployment, model output and resulting clinical risk score will not be communicated to the treating clinicians. during the study period, investigators will review charts daily for all patients admitted to the golisano children's hospital picu, a 12-bed facility adjacent to our 15-bed pediatric cardiac intensive care unit (pcicu). using a standard protocol to screen and identify patients by chart review, investigators will generate a list of patients who meet aki kdigo criteria by scr and urine output, along with recorded clinical information about these patients. at the conclusion of the study period, this list will be used as the "gold standard" and compared to the automated screening tool to determine the tool's test characteristics. model assessment outcomes include sensitivity, positive predictive value (ppv), and number needed to alert (nna) to prospectively identify aki in a population of critically ill children. additional outcomes include timeliness of identification based on model implementation (e.g., measured timestamps of algorithm prediction compared to manual, prospectively identified aki development). additionally, investigators will report interventions and clinical outcomes of the prospectively identified patients with aki, stratified by those predicted early by the model (within 24 hours of admission) versus not.

Eligibility criteria:
inclusion criteria: * patients admitted to the pediatric intensive care unit or pediatric cardiac intensive care unit * age \> 30 days and \< 18 years exclusion criteria: * discharged less than 12 hours after admission * aki at 12 hours of admission by kdigo serum criteria

Keywords: machine learning pediatrics critical care
vilazodone for menopausal hot flashes

Conditions: Hot Flushes

Summary: this is a pilot study to determine proof in principle that vilazodone, a selective serotonin reuptake inhibitor and 5ht1a agonist, reduces the frequency and severity of menopausal hot flashes relative to placebo. a secondary aim is to evaluate improvement in menopause-related quality of life.

this is a proposal to conduct a small clinical trial for proof in principle that vilazodone reduces the frequency and severity of menopausal hot flashes. an additional exploratory aim is to identify improvement in menopause-related quality of life. healthy, perimenopausal women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats per day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of vilazodone or matching placebo pills. flexible dosing of vilazodone will start at 10 mg once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at week 3 if unimproved. the primary outcome assessments are the frequency and severity of hot flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean scores from the daily diaries). the secondary outcome is clinical improvement, defined as hot flash frequency \>=50% decrease from baseline. treatment-emergent adverse events will be monitored and patient ratings of tolerability will be obtained.

Eligibility criteria:
inclusion criteria: * women ages 45-60 years * amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy. * 4 or more moderate or severe hot flashes or night sweats per 24 hour period (28/week) as recorded on daily diaries in 3 screening weeks. * hot flashes/night sweats rated as moderate to severe and/or bothersome (moderately to a lot) on 4 or more days/nights in each screen week. * in general good health. * signed informed consent. exclusion criteria: * psychotropic medications currently or within the last 30 days. * current use of hormonal medications such as hormone therapy or hormonal contraception or any treatment for hot flashes (prescription, over-the-counter or herbal). * drug or alcohol abuse in the past year. * lifetime diagnosis of psychosis or bipolar disorder. * suicide attempt in the past 3 years or any current suicidal ideation. * current major depression. * not using a medically approved, non-hormonal method of birth control if sexually active and not postmenopausal (12 or more months since last menstrual period or bi-lateral oophorectomy). * pregnancy, intending pregnancy or breast feeding. * any severe of unstable medical illness, e.g., breast or ovarian cancer, seizure disorders, etc. * current participation in another intervention study. * inability or unwillingness to complete study procedures.

Keywords: menopause hot flashes vilazodone
rise rct for nurse leaders

Conditions: Stress; Burnout

Summary: the purpose of this study is to determine whether rise for nurse leaders has a significant impact on nurse leaders' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.


Eligibility criteria:
inclusion criteria: * adult ≥ 18 years old * licensed as an rn * unit-based nurse leader (i.e., assistant nurse manager, nurse manager) employed by adventhealth in a hospital-based setting at the altamonte springs, apopka, celebration, daytona beach, deland, east orlando, fish memorial, kissimmee, new smyrna beach, orlando, palm coast, waterman, or winter park campus * able to speak, read, and understand english fluently * able to provide informed consent * willing and able to comply with all study procedures and requirements for the duration of the study. exclusion criteria: * employed as a direct care nurse or in another level of nursing leadership (i.e., director of nursing, executive leader) * a study participant of irbnet #1504917 titled a pilot study of rise for nurse managers
lidocaine-prilocaine cream versus rectal meloxicam on relief of post-episiotomy pain

Conditions: Postpartum

Summary: postpartum perineal pain is a very common complaint. it can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. early pain management is thus relevant to provide relief and prevent chronicity. perineal pain is particularly common following childbirth. macarthur 2004, in a prospective cohort study involving 447 women in canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum


Eligibility criteria:
inclusion criteria: 1. primiparas 2. normal vaginal delivery 3. mediolateral episiotomy 4. ability to understand and the willingness to sign a written informed consent exclusion criteria: 1. patients who had postpartum hemorrhage 2. patients who had manual removal of the placenta 3. patients with contraindications to non steroidal drugs 4. patients with a multiple perineal lacerations
cpr feedback devices

Conditions: Cardiac Arrest

Summary: the aim of the study was to compare two methods of training in cpr, standard basic life support and cpr using cpr feedback device.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study exclusion criteria: * not meet the above criteria * wrist or low back diseases
intense pulsed light as an adjunctive to bromonidine for the treatment of rosacea

Conditions: Rosacea

Summary: this is an interventional and prospective study. the study is designed to evaluate the additional benefits of a combination of ipl treatment and local application of bromonide 0.33% gel in the treatment of erythematotelangiectatic (etr) and papulopustular (ppr).

patients would be treated with full face application of bromonide 0.33% gel once daily for three months. in addition half of the patients' face would be subjected to three ipl treatment sessions three weeks apart from each other.

Eligibility criteria:
inclusion criteria: * patient (male or female) must be over 18 yaers old of age and fulfil one of the following: 1. suffer from etr 2. suffer from ppr 3. suffer from a combination of etr and ppr. exclusion criteria: * 1.under 18 years old of age. 2.pregnant women. 3.systemic treatment of rosacea at the previous six months before enrollment. 4.topical treatment of rosacea at the previous one month before enrollment. 5.phymatous or occular rosacae.

Keywords: rosacea, bromonidine, intensed pulse light
comparative efficacy of phenylbutyrate (pba) vs. benzoate in urea cycle disorders

Conditions: Urea Cycle Disorders, Inborn

Summary: the investigators will study and compare how effectively sodium phenylbutyrate, sodium benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. subject participation will require three, separate, four-day study periods at least one week apart. during one study period (also called a treatment arm), subjects will take sodium phenylbutyrate; during another they will take sodium benzoate; during another they will take a combination of the two medications. we expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or a combination of the two.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * subjects with (a) a history of frequent dietary protein intolerance, (b) a history of chronic or acute liver diseases which may result in altered hepatic synthetic capacity (e.g., hepatitis), (c) acute or chronic disease or on medications that in the opinion of the clinical investigators will interfere with the measurements (e.g., drugs which may have hepatotoxicity as potential side effects), (d) a physical disability that will interfere with their ability to either conform to the dietary regimes or undergo the isotopic infusions, (e) pregnancy or recent (\<6 months)/current lactation, (f) intercurrent evidence of significant hyperammonemia (more than 100 µmol/l), (g) any clinical abnormality of grade 3 or greater according to the common terminology criteria for adverse events v.4.0 (ctcae), (h) any condition(s) not covered by the ctcae, or (i) a severe or life-threatening toxicity at screening, will be excluded from the study. subjects taking ammonia scavenger medications will not be enrolled.

Keywords: urea cycle disorders
use of ulipristal acetate in induction of second trimester missed abortion

Conditions: Induction of Second Trimester Abortion

Summary: the aim of this work is to assess the effectiveness and safety of ulipristal acetate in the management of 2nd trimester missed abortion along with misoprostol in pregnant women with previous caesarean section versus the use of misoprostol only with placebo as regards the time needed for abortion,hypothesis: in pregnant women with 2nd trimester missed abortion with previous caesarean section , ulipristal acetate may decrease the time interval to achieve abortion when combined with misoprostol in comparison to misoprostol alone.the included women divided to 2 groups group a: will receive ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to figo guidelines 2017.group b: will receive placebo then 12 hours later start misoprostol 100µg every 6 hours buccal according to figo guidelines 2017. then we assess induction-to-abortion interval time.


Eligibility criteria:
inclusion criteria: • women with 2nd trimester missed abortions * gestational age 13-26 weeks. * women with a previous caesarian section scar,(para 1cs till para 4 cs). * women counseled and chose medication abortion rather than surgical evacuation exclusion criteria: * women with an accompanying medical disorder such as: preeclampsia, diabetes mellitus or heart disease. * primigravida women or non scarred uterus. * women with previous myomectomy or hysterotomy scar or upper segment caesarean section scar. * induction of abortion in women with congenital fetal malformations or positive fetal pulsations due to medical disorder. * women with placenta previa . * allergy or contraindications to either ulipristal acetate or misoprostol. * women with inevitable abortion in the form of vaginal bleeding or uterine contractions
effects of foundation and functional inspiratory muscle training in non-specific chronic low back pain

Conditions: Low Back Pain, Mechanical; Low Back Pain, Chronic; Non Specific Chronic Low Back Pain

Summary: this study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. in this study, participants will be randomly divided into 3 groups. the first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. the second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. the third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. there is no interventional method in the evaluations. pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. in physical measurements, participant's aerobic capacity will be measured with the 2-minute walk test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the mip/mep device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the biodex balance device, and participants's muscle thickness with an ultrasound.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * being between the ages of 18-65, * having low back pain that has been ongoing for at least 3 months (12 weeks), * having a visual analog scale (vas) of pain intensity of ≥3, * being right-hand dominant. exclusion criteria: * not volunteering to participate in the study, * having a history of cancer, * having a spinal infection, * having a rheumatological condition, * having a spinal fracture, * having red flag signs (sudden and unexpected weight loss, fever, etc.) * having a psychological disorder, * having a previous spinal surgery, * having radiculopathy (neuropathic pain along the lower extremity due to nerve root compression), * not continuing home exercises more than 80%, * having an anatomical and congenital abnormality

Keywords: low back pain respiratory muscle strength muscle training classical physiotherapy ultrasound
adipose derived cells for chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * a prior diagnosis of moderate or severe copd * gold iii and iv * age between 18 and 85 years exclusion criteria: * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease patients known to have tested positive for hiv, htlv, hbv, hcv, cmv (igm \> igg) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * severe asthma that would contraindicate surgery * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * patients with alpha-1 * unwilling and/or not able to give written informed consent.

Keywords: copd pulmonary stem cells emphysema lungs
investigation of mohs surgical margins using two photon microscopy

Conditions: Basal Cell Carcinoma

Summary: the goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during mohs surgery. the main question it aims to answer is: • how similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology

this study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (tpfm) to evaluate surgical margins followed by standard of care frozen section analysis (fsa) for confirmation. to protect patients, following tpfm imaging, patients will receive standard of care evaluation using cryosectioned h\&e slides, thus all patients will receive standard of care confirmation following experimental imaging. individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using tpfm. following imaging, specimens will be cryosectioned as per normal procedure. following treatment, the results of the tpfm evaluation of each mohs excisions will be compared to the results from fsa to assess the overall accuracy of tpfm and to determine if tpfm would result in changes to patient care if used without fsa confirmation.

Eligibility criteria:
inclusion criteria: * undergoing treatment for bcc with mohs surgery at the performance site * able to read and understand consent form exclusion criteria: * none